OBJECTIVE: To determine the effect of antibiotic treatment for acute otitis media in children between 6 months and 2 years of age. DESIGN: Practice based, double blind, randomised, placebo controlled trial. SETTING: 53 general practices in the Netherlands. SUBJECTS:240 children aged 6 months to 2 years with the diagnosis of acute otitis media. INTERVENTION: Amoxicillin 40 mg/kg/day in three doses. MAIN OUTCOME MEASURES: Persistent symptoms at day four and duration of fever and pain or crying, or both. Otoscopy at days four and 11, tympanometry at six weeks, and use of analgesic. RESULTS:Persistent symptoms at day four were less common in the amoxicillin group (risk difference 13%; 95% confidence interval 1% to 25%). The median duration of fever was two days in the amoxicillin group versus three in the placebo group (P=0.004). No significant difference was observed in duration of pain or crying, but analgesic consumption was higher in the placebo group during the first 10 days (4.1 v 2.3 doses, P=0.004). In addition, no otoscopic differences were observed at days four and 11, and tympanometric findings at six weeks were similar in both groups. CONCLUSIONS: Seven to eight children aged 6 to 24 months with acute otitis media needed to be treated with antibiotics to improve symptomatic outcome at day four in one child. This modest effect does not justify prescription of antibiotics at the first visit, provided close surveillance can be guaranteed.
RCT Entities:
OBJECTIVE: To determine the effect of antibiotic treatment for acute otitis media in children between 6 months and 2 years of age. DESIGN: Practice based, double blind, randomised, placebo controlled trial. SETTING: 53 general practices in the Netherlands. SUBJECTS: 240 children aged 6 months to 2 years with the diagnosis of acute otitis media. INTERVENTION: Amoxicillin 40 mg/kg/day in three doses. MAIN OUTCOME MEASURES: Persistent symptoms at day four and duration of fever and pain or crying, or both. Otoscopy at days four and 11, tympanometry at six weeks, and use of analgesic. RESULTS: Persistent symptoms at day four were less common in the amoxicillin group (risk difference 13%; 95% confidence interval 1% to 25%). The median duration of fever was two days in the amoxicillin group versus three in the placebo group (P=0.004). No significant difference was observed in duration of pain or crying, but analgesic consumption was higher in the placebo group during the first 10 days (4.1 v 2.3 doses, P=0.004). In addition, no otoscopic differences were observed at days four and 11, and tympanometric findings at six weeks were similar in both groups. CONCLUSIONS: Seven to eight children aged 6 to 24 months with acute otitis media needed to be treated with antibiotics to improve symptomatic outcome at day four in one child. This modest effect does not justify prescription of antibiotics at the first visit, provided close surveillance can be guaranteed.
Authors: P W Hermans; M Sluijter; K Elzenaar; A van Veen; J J Schonkeren; F M Nooren; W J van Leeuwen; A J de Neeling; B van Klingeren; H A Verbrugh; R de Groot Journal: J Infect Dis Date: 1997-06 Impact factor: 5.226
Authors: P H Kaleida; M L Casselbrant; H E Rockette; J L Paradise; C D Bluestone; M M Blatter; K S Reisinger; E R Wald; J S Supance Journal: Pediatrics Date: 1991-04 Impact factor: 7.124
Authors: Roderick P Venekamp; Marc J M Bonten; Maroeska M Rovers; Theo J M Verheij; Alfred P E Sachs Journal: CMAJ Date: 2012-08-07 Impact factor: 8.262
Authors: Alejandro Hoberman; Jack L Paradise; Howard E Rockette; Jong-Hyeon Jeong; Diana H Kearney; Sonika Bhatnagar; Timothy R Shope; Gysella Muñiz; Judith M Martin; Marcia Kurs-Lasky; MaryAnn Haralam; Marcia A Pope; Jennifer P Nagg; Wenchen Zhao; Mohammad Kowser Miah; Jan Beumer; Raman Venkataramanan; Nader Shaikh Journal: Antimicrob Agents Chemother Date: 2017-06-27 Impact factor: 5.191